Kornimate/medical-research-clean huggingface dataset:
short-term effectiveness of gabapentin versus placebo in acute lumbosacral radiculalgia by herniation disc (grade)

Conditions: Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Summary: the study consists in evaluating the analgesic efficacy of gabapentin versus placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation. in addition to the usual analgesic treatment, the patient will receive gabapentin or placebo. during the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

the objective of the study is to evaluate the analgesic efficacy of gabapentin versus placebo in 72h for hospitalised patients suffering from acute lumbosacral radiculalgia due to disc herniation. after signing the consent form, patient's clinical data will be collected and the patient will be allocated to one treatment arm by the randomisation process (ratio 1:1 and stratified on the strong opioid intake). two treatment arms are possible : * experimental group: gabapentine per os * day1:300 mg * day 2: 600 mg * day3 : 900 mg * control group: placebo (same dosage per day as gabapentine).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain), * inpatient management for a minimum of 72 hours after inclusion, * initial radiculalgia vas ≥ 4 (moderate to severe pain), * concordant disc herniation between clinical symptomatology and imaging (ct or mri) less than 3 months, * written consent signed by the patient, * affiliation to a social security system * for women of childbearing age, use of effective contraception exclusion criteria: * motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications), * chronic neuropathic pain in the lower limb affected by radiculalgia, * lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours, * patient already on gabapentin or pregabalin, or having taken these treatments in the 7 days prior to inclusion * contraindication to gabapentin (hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide) * creatinine clearance \< 30ml/min, * hemodialysis patient, * body weight \< 50kgs, * transplant patient * patient under guardianship or curatorship * pregnant or breastfeeding woman

Keywords: radiculalgia lumbosacral spine disc herniation gabapentin
14473 - d9126c00001 proof of principle study - effect of azd2066 on transient lower esophageal sphincter relaxations

Conditions: Reflux Episodes

Summary: the purpose of the study is to assess the safety and tolerability of azd2066 and to explore the effect of a single dose of azd2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.


Eligibility criteria:
inclusion criteria: * provision of written consent prior to any study specific procedures. * healthy subjects, age 18-45 years inclusive. females must be of no childbearing potential or must use a highly effective contraceptive method. * clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator. exclusion criteria: * clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to who risk categories 2, 3 or 4, as judged by the investigator. * a measured les pressure of \< 5mm hg. * history of previous or ongoing psychiatric disease/condition.

Keywords: gerd tlesr reflux
autologous adipose tissue-derived mesenchymal stem cells (admscs) for osteoarthritis

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis Shoulder

Summary: this is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). the study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (koos and kss for oa-knees: hoos and hhs for oa-hips and ases and css for oa-shoulders).


Eligibility criteria:
inclusion criteria: * age above 18 years * male or female * subjects in study group must have banked admscs at celltex (already passed communicable disease screen tests for hiv, syphilis and hepatitis b and c during banking stage) * must understand and voluntarily sign an informed consent for study participation obtained prior to undergoing any study-specific procedures * must be diagnosed as oa-knees, oa-hips, or oa-shoulders by radiographic criteria and physical examination. exclusion criteria: * participation in another clinical study (with use of another investigational medical product) within 3 months prior to study treatment start * unwillingness or inability to comply with study procedures * patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc. * clinically active malignant disease * previous thrombotic disorder * history of known pulmonary embolism or known secondary anti-phospholipid syndrome * known or suspected hypersensitivity to any components used to culture the admscs, e.g. bsa and sulfur-containing products (e.g., dmso) * major trauma or surgery within 14 days of study treatment start * mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study * alcohol, drug, or medication abuse within one year prior to study treatment start * any condition that, in the investigator's opinion, is likely to interfere with evaluation of the admsc therapy or satisfactory conduct of the study * irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions * patients or family history with a hypercoagulable status, such as protein c/protein s deficiency, factor v leiden, prothrombin gene mutation, dysfibrinogenemia, etc. * history of long-term use of immunosuppressive agents * organ transplants in the previous 6 months * pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study

Keywords: autologous adipose-derived stem cells (admscs)
efficacy and safety of long term use of hcg or hcg plus hmg in males with isolated hypogonadotropic hypogonadism (ihh)

Conditions: Isolated Hypogonadotropic Hypogonadism; Kallmann Syndrome; Infertility

Summary: this study will evaluate the efficacy and safety of long term use of hcg alone or hcg plus hmg in the treatment of male patients with isolated hypogonadotropic hypogonadism (ihh). one third of the participants will receive hcg treatment alone and the other third of the participants will receive hcg treatment alone for six months, then the hmg will be added. and the last third of the participants will receive hcg and hmg treatment since the beginning of the treatment.

the efficacy of hcg alone or hcg plus hmg in the treatment of male ihh patients was reported in some studies. however, these studies were mostly non-randomized controlled studies with small size of samples and short follow-up time. there was also no reported study which aimed to compare the efficacy and safety of long term use of hcg or hcg plus hmg in the treatment of male patients with ihh. so the difference in the efficacy and safety between long term use of hcg alone and hcg plus hmg in the treatment of ihh is unknown. in different reported studies, the hcg plus hmg treatment had two regimens: using hcg alone for six month, then hmg was added and using hcg plus hmg since the beginning of the treatment. the difference in the efficacy and safety between the above two regimes is also unknown.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18, ≤ 45 years old; 2. adolescent dysplasia or loss of puberty: genital tanner score ﹤ 5, pubic hair tanner score ﹤ 5; 3. serum fsh and lh levels are low or in normal low value, testosterone was lower than normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference range of tongji hospital affiliated to tongji medical college, huazhong university of science and technology); 4. with or without olfactory loss/reduction; 5. other pituitary hormone levels are normal; 6. head mri examination is normal; 7. fertility is desired currently or will be desired in the future; 8. understand and sign the informed consent form. exclusion criteria: 1. primary hypogonadism; 2. acquired hypogonadotrophic hypogonadism; 3. a history of treatment with pulsed gnrh, hcg and fsh related hormones; 4. receive testosterone replacement therapy for more than 6 months; 5. history of cryptorchidism or cryptorchidism; 6. the sperm density before treatment ≥1×10\^6/ml; 7. moderate or severe liver and kidney dysfunction (alt\>120iu/l, ast\>80iu/l, cr\>115μmol/l); 8. the karyotype is 45,x or 47,xxy and 48, xxxy and other abnormal karyotypes; 9. true hermaphroditism and pseudohermaphroditism; 10. sex hormone abnormalities caused by adrenal lesions; 11. hypogonadism secondary to other systemic diseases; 12. abnormal secretion of hormones caused by brain lesions (such as pituitary tumors); 13. there are other hormone abnormalities in the pituitary; 14. there are contraindications for the treatment with hcg or hmg.

Keywords: gonadotropin treatment human chorionic gonadotropin human menopausal gonadotropin
antiepileptic drugs and vascular risk markers

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.

there is some evidence that certain seizure medicines may raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes, however, more research is needed. individuals with acute subarachnoid hemorrhage traditionally are treated with seizure medicines, but it is not clear which one is best, or if any such medication is necessary at all. this study is intended to find out if certain seizure medications raise levels of cholesterol and other blood components which could lead to an increased risk of heart attacks and strokes. in this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment with one of three different seizure medicines-phenytoin, valproate, or levetiracetam-or to receive no seizure medication at all. in each participant, cholesterol and other blood markers that relate to heart attack and stroke risk will be measured shortly after hospital admission and again 8 weeks later. at the 8-week point most participants will have their seizure medication discontinued, and the same blood tests will be repeated. information from this study could lead to changes in how seizure medications are prescribed both in the subarachnoid hemorrhage population and in other people who are prone to seizures.

Eligibility criteria:
inclusion criteria: * acute subarachnoid hemorrhage, hunt-hess grades i-iv * within 48 hours of admission exclusion criteria: * grade v subarachnoid hemorrhage * being treated with a lipid-lowering agent * contraindication to phenytoin, valproate, or levetiracetam (e.g. history of allergy to one of these agents) * contraindication to receiving no antiepileptic drug treatment (e.g. history of pre-existing epilepsy, seizure activity on admission eeg)

Keywords: vascular risk lipid fractions lipoprotein(a) c-reactive protein subarachnoid hemorrhage antiepileptic drug randomized seizure cholesterol
prostate bipolar enucleation and resection versus open prostatectomy

Conditions: Benign Prostatic Hyperplasia

Summary: benign prostatic hyperplasia (bph) is a frequent disease in aging men accompanied by bladder outlet obstruction (boo). open prostatectomy (op) is still considered the first-line treatment for more than 80 ml prostate size. in this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (tberp) was compared to the standard open prostatectomy.

benign prostatic hyperplasia (bph) is a frequent disease in aging men accompanied by bladder outlet obstruction (boo). open prostatectomy (op) is still considered the first-line treatment for more than 80 ml prostate size. in this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (tberp) was compared to the standard open prostatectomy. this is a comparative, prospective study conducted on men over 50 years.the patients were randomly distributed into two groups treated by tberp and op. patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, ipss, pvr, prostate volume, early complications (recatheterization, urine retention, uti and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).

Eligibility criteria:
inclusion criteria: * male patients * age more than 50 years * prostate size of more than 80 ml * ipss ≥ 8, and maximum urinary flow rate (qmax) ≤ 15 ml/s * indications for surgery * refractory retention (failed ≥1 trial of voiding). * associated bladder stones. * associated recurrent gross hematuria. * associated with recurrent infections. * associated renal insufficiency. * bother symptoms refractory to medical treatment. exclusion criteria: * uncorrectable coagulopathy. * patient with active uti. * prostate less than 80 ml. * severe associated comorbidities. * previous urethral, prostate, and bladder surgeries, * patients diagnosed with neurogenic bladder. * patients diagnosed with prostate cancer.

Keywords: transurethral enucleation transurethral enucleation and resection of the prostate plasma enucleation prostate enucleation open prostatectomy bph benign prostatic hyperplasia
evaluation of a xience v® endoprothesis used for coronary angioplasty, for lppr (list of reimbursable products and services) indications in patients monitored for 2 years in france

Conditions: Coronary Artery Disease

Summary: the objective of this study is to prepare elements of response to the haute autorité de santé (high health authority) of france, which is expecting data relating to the routine use of xience v® endoprothesis within the 5 years following its marketing.


Eligibility criteria:
inclusion criteria: all patients enrolled in the study must : * be at least 18; * be covered by social security * agree to be enrolled in the study (sign the informed consent after reading the information letter). in addition, the xience v endoprothesis implantation must be performed following the lppr indications here under : treatment of coronary heart disease attributable to de novo lesions (reference vessel with a 2.5 to 3.5 mm) of native coronary arteries, solely in the following groups of patients : * patients with diabetes ; * lesions of small vessels (diameter \< 3 mm); * long lesions (longer than 15 mm) ; * stenosis of proximal anterior intraventricular septum . the use of the xience v stent is limited to one per patient, except : * in case of acute occlusive dissection where three stents, maximum, may be covered ; * for the pluritroncular diabetic patient, in case a bypass is contra-indicated : a stent per artery, with a limit of three per patient, may be covered. exclusion criteria: * pregnant women * patients with: * a non cardiac vital prognosis endangered during the year following the implantation ; * less than 72 hours myocardial infarction ; * lower left ventricular ejection fraction \< 30 % ; * an allergy to the platelets antiaggregant treatment, to heparin, chrome cobalt alloy, or to the angiography contrast medium ; * a stenosis of the unprotected common trunk; * a lesion with calcifications that cannot be pre-dilated; * a thrombus that can be detected by angiography on the lesion to be treated ; * an intra-stent re-stenosis. are also excluded : * patients having had an angioplasty with implantation of an endoprothesis on the same vessel; * patients having had an angioplasty with implantation of an endoprothesis during the 6 previous months ; * patients unable to keep a treatment associating aspirin and thiénopyridines for at least 6 months; * patients residing abroad or who cannot be monitored according to the modalities of the study ; * patients unable to give on their own free will their informed consent ; on the other hand, in absence of clinical validation, the other sub-groups of at risk patients (notably bifurcation lesions and pluritroncular lesions) cannot be considered , taken alone, as indications for the use of xience v.

Keywords: drug eluting stents stents angioplasty chronic coronary occlusion stent thrombosis vascular disease myocardial ischemia coronary artery stenosis coronary disease coronary artery disease coronary restenosis
parkinson´s disease, aerobic exercise and photobiomodulation

Conditions: Parkinson Disease

Summary: the aim of the present study was to assess the effects of a combined therapy of aerobic exercise and transcranial photobiomodulation upon the cardinal motor sympomts of parkinson´s disease of a group of parkinson´s disease patients. it was hypothesized that aerobic exercise and transcranial photobiomodulation would yield significant benefits in the cardinal motor sympomts of the illness.


Eligibility criteria:
inclusion criteria: * diagnosis with idiopathic pd and rated 1-2 on the hoehn and yahr scale. * no type of dementia as assessed by the mini-mental state examination. * able to stand for 2 min without assistance. * able to walk 10 m without assistance. exclusion criteria: * individuals were excluded if they suffered a neurological disease other than pd, if the subject has an implant of any kind in the head (e.g., stent, clipped aneurysm, embolized arteriovenous malformation, implantable shunt - hakim valve) or if they did not meet the eligibility criteria.
avoidable hospitalizations/ emergency department visits- systematic review and meta-synthesis of qualitative research

Conditions: Diabetes; Heart Failure; Chronic Obstructive Pulmonary Disease; Asthma; Hypertension; Urinary Tract Infections; Pneumonia, Bacterial

Summary: the aim of the study is to synthesize qualitative evidence related to preventable hospitalizations/ emergency department visits from the perspectives of patients, their families/caregivers, health care providers, and stakeholders, in the hope to identify generalizable conclusions about why social risk factors matter to preventable hospitalizations/ emergency department visits

the present study is a qualitative systematic review and meta-synthesis study. the study primarily focused on the qualitative studies that collected and analyzed narratives from patients who experienced preventable hospitalizations. the information from their families, health care providers, and stakeholders in the qualitative studies are also included. the data collections from patients occurred during their hospital stay, emergency department stay, or after discharge to the community are included. patients included all ages and gender, regardless of their race/ethnicity and countries. the qualitative studies must be published in peer-reviewed journals, with language as english and no restriction on publication date or country of origin. two authors (hc and hl) independently screened the title and reviewed abstracts, then full texts for eligibility. thorugh synthesizing, the present study is expected to develop themes and sub-themes related to preventable hospitalizations/emergency department visits, in the hope to assist policymakers health care professionals, and stakeholders in properly addressing the underlying factors leading to preventable hospitalizations/emergency department visits .

Eligibility criteria:
patients were admitted to hospitals and/ or visited the emergency department due to preventable conditions, including diabetes acute complications, diabetes chronic complications, uncontrolled diabetes, low-extremity amputation due to diabetes, copd, heart failure, hypertension, urinary tract infection, and pneumonia. patients' families and their health care providers are also included. exclusion criteria: patients with dementia, mental illness, or cancer

Keywords: meta-analysis qualitative study systematic review social determinants of health
a comparison of peak aqueous penetration of acuvail (ketorolac 0.45%), xibrom (bromfenac 0.09%), and nevanac (nepafenac 0.1%)in patients undergoing phacoemulsification

Conditions: Cataracts

Summary: approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either acuvail, xibrom, or nevanac. subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. at the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. the sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older. * scheduled for cataract surgery by phacoemulsification. * subject must be willing to comply with all study requirements and be willing to give informed consent. exclusion criteria: * any subject that has a history of uveitis or active iritis. * subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months. * no ocular use of prostaglandins within 2 weeks of surgery. * use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (nsaids) or immunosuppressants within 14 days prior to surgery. * contraindications to nsaids. * active ocular infection.
acoustical properties of speech as indicators of suicidal risk

Conditions: Depression

Summary: this project is focused on acoustical, sound, analysis of speech in order to identify vocal characteristics of speech that are associated with suicidality. speech samples will be collected from four populations with different mental health status: suicidal, ideational suicidal, depressed and those in remission from depression, (the control group). speech of subjects will be recorded during routine diagnostic interview sessions. the speech samples will be acoustically analyzed via digital computer algorithms. the acoustical differences among those groups will be determined based on the statistical analysis.


Eligibility criteria:
inclusion criteria: * age range: 25 to 65 years of age * participants must be depressed or be in remission from depression (have a history of depression) exclusion criteria: * speech impediment * intoxication at time of interview

Keywords: depression suicide voice